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Behavioral Intervention

Genetic Testing and Counseling for Hereditary Cancer

N/A

Recruiting

Led By Jose Rauh-Hain, MD,MPH

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)

18 years of age or older

Must not have

Has no at-risk relatives meeting inclusion criteria

Has already been tested for the variant identified in the proband

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether providing family members with education or other help increases genetic testing rates in families affected by hereditary cancer.

Who is the study for?

This trial is for adults in the U.S. who speak English or Spanish, have internet access, and a known genetic mutation linked to certain cancers (like BRCA1/2 or Lynch Syndrome) in their family. They should have at least one relative also at risk but can't join if they've already been tested negative for these mutations or don't have any relatives who could be affected.

What is being tested?

The study tests an intervention called IGNITE-TX which includes a web platform and personal navigators to increase genetic testing rates among families with hereditary cancer syndromes. It compares the effectiveness of this approach with free genetic counseling and testing services.

What are the potential side effects?

Since this trial involves genetic testing and counseling rather than medication, traditional side effects are not expected. However, participants may experience emotional or psychological impacts from learning about their genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can show that a close family member has a harmful gene variant linked to cancer.

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I am 18 years old or older.

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I have a harmful mutation in BRCA1/2 or genes related to Lynch syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My family members do not qualify for this clinical trial.

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I have been tested for the same genetic variant found in my family member.

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My family has no history of HBOC or Lynch syndrome.

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My genetic test for cancer did not show any harmful mutations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 4 (IGNITE-TX and free genetic testing and counseling group)Experimental Treatment3 Interventions

Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator

Group II: Group 3 (IGNITE-TX Group)Experimental Treatment3 Interventions

Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm

Group III: Group 2 (Free genetic testing and counseling group)Experimental Treatment3 Interventions

Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study

Group IV: Group 1 (Standard of Care Group)Active Control1 Intervention

Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing. Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing

0 / 7Eligibility criteria met